Executive Medical Director, Ophthalmology, Clinical Development

$344,000 - $412,867/Yr

Insmed Incorporated

Full-time - Executive

Professional, Scientific, and Technical Services

About the position

The Executive Medical Director of Ophthalmology, Clinical Development is responsible for leading clinical programs across various diseases and supervising the clinical development team. This role involves medical monitoring, oversight of clinical studies, and collaboration with research and commercial departments to expand the company's ophthalmology pipeline.

Responsibilities

• Design and implement clinical development strategy and protocols for high-quality clinical programs.
• Serve as the therapeutic area lead for the ophthalmology clinical development team, collaborating with various departments.
• Provide medical leadership for clinical operational strategy, including site selection and enrollment.
• Conduct medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
• Ensure the medical integrity of clinical study reports and data interpretation.
• Author or oversee clinical sections of regulatory submissions and represent the company at regulatory meetings.
• Prepare safety charters and management plans in a cross-functional team.
• Support or prepare data interpretation and clinical trial reports.
• Prepare Investigator Alert letters and SAE reports as required.
• Represent the company to external stakeholders supporting clinical trials.
• Analyze, interpret, and organize data for presentations and publications.
• Interact with external experts and organize advisory board meetings.
• Maintain expertise in ophthalmologic diseases through literature review and attendance at meetings.
• Develop and manage budgets for clinical development plans and report progress to stakeholders.
• Participate in the strategic direction of the gene therapy leadership team.
• Support business development and product evaluation.
• Provide medical expertise to internal and external customers.
• Coach, manage, and mentor direct reports.

Requirements

• MD, DO, or foreign equivalent with clinical experience.
• 10+ years of management experience in ophthalmology clinical development.
• Clinical residency training in ophthalmology.
• 10+ years of global experience in ophthalmology clinical development in the pharmaceutical/biotech industry.
• Knowledge of ICH-GCP and FDA regulatory guidelines.

Nice-to-haves

• A PhD in addition to the above qualifications.
• Pediatric experience.
• Gene therapy experience.
• Experience with retinal diseases.

Benefits

• Flexible approach to work location and hours.
• Competitive compensation package including bonus.
• Stock options and RSU awards.
• Employee Stock Purchase Plan (ESPP).
• Flexible vacation policy.
• Generous paid holiday schedule and winter break.
• 401(k) plan with company match.
• Medical, dental, and vision plans.
• Company-provided life and AD&D insurance.
• Short and long-term disability benefits.
• Pet, legal, and supplemental life insurance options.
• Flexible spending accounts for medical and dependent care.
• Accident and hospital indemnity insurance.
• Employee Assistance Program (EAP).
• Mental health online resources.
• Well-being reimbursement.
• Paid leave benefits for new parents.
• Paid time off to volunteer.
• On-site fitness center at headquarters.